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Magne B6 medication recalled in Poland due to quality issues
The Chief Pharmaceutical Inspectorate has ordered an immediate nationwide recall of a specific batch of the medication Magne B6 in Poland. The recall affects the 60-tablet coated tablet packaging, specifically batch number KV023, which has an expiration date of December 2027.
The decision follows quality testing conducted by the National Institute of Medicaments, which revealed that the magnesium in this batch does not release from the tablets within the required 90-minute timeframe. This discrepancy in the active substance release rate may impact the medication's effectiveness.
Opella Healthcare Poland, the responsible entity, noted that differences in testing results might stem from variations in laboratory equipment used during analysis. However, the regulatory authority has maintained the recall mandate. Distribution has been halted, and the company is required to withdraw the affected batch from pharmacies and wholesalers across the country.
Entities
Chief Pharmaceutical Inspectorate · National Institute of Medicaments · Opella Healthcare Poland